# K212827: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Decided: Dec 6, 2021 after 94 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042805 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue), Harbour Health, LLC (2021) Summary page 5.

## Indications for use
JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs and their breakthrough detection times are as follows: Tested Chemotherapy Drug Name & Concentration Carmustine (BCNU) (3.3 mg/ml) Carboplatin (10 mg/ml) Cisplatin (1 mg/ml) Cyclophosphamide (Cytoxan) (20 mg/ml) Dacarbazine (10.0 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Paclitaxel (6 mg/ml) Thiotepa (10 mg/ml) Vincristine Sulfate (1 mg/ml) Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes Warning: Do not use with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K212827
Methodology: https://510kreport.com/methodology